Tag Archives: CDC

Preventing Youth Violence: Where’s the Research?

Photo courtesy of Thierry Geoffroy (Wikimedia CC)

Instead of focusing exclusively on risk factors for youth violence, it’s time to start looking at protective factors.  At least that’s what a CDC expert panel recommended in a special supplement of the American Journal of Preventive Medicine.

Homicide continues to be the second leading cause of death for youth aged15-24, and the leading cause of death for African American youth, according the CDC. More than 700,000 young people aged 10 to 24 were treated in emergency departments in 2010 for injuries sustained due to violence.

While identifying risk factors for teen violence is a necessary component of combating the problem, the experts recognize that it’s also important to identify factors that protect youth against youth embracing violence — such as resilience, positive youth development and community assets. “Most youth, even those living in high risk situations, are not violent and more must be learned about the factors that are helping youth, protecting them from engaging in violent behavior so that others can benefit,” the experts wrote in the supplement.

The CDC convened the Expert Panel on Protective Factors for Youth Violence Perpetration to clarify unresolved definitional and analytic issues on protective factors; review the state of evidence regarding the factors that appropriately can be labeled as direct protective, buffering protective, or both; carry out new analyses of major longitudinal surveys of youth to discover new knowledge about protective factors; an assessing the implications of research identifying protective factors for prevention programs, policies, and future research. This supplement presents the group’s work on direct protective factors — in particular identifying factors that exhibit mostly direct protective effects.

For more information about youth violence in the United States, check out a number of resources available on the CDC’s violence prevention Web page.

Kerri Wachter

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Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Influenza Toys with the Human Race

The current U.S. influenza seasonal epidemic, the mildest in years, is in its death throes, based on infection trends over the past several weeks, including the most recent data released on May 11 by the Centers for Disease Control and Prevention.

During the week that ended on May 5, 13.7% of U.S. respiratory surveillance specimens tested positive for influenza, continuing the clear downhill slope of U.S, flu cases since this season’s U.S. epidemic peaked at 30% positive during the week of March 11-17. The CDC hasn’t yet declared the current, 2011-2012 flu-season’s epidemic, which started in late February, officially over—it can’t until the influenza-positive rate falls back below 10%–but the epidemic curve’s steep downward track (see graphic) is as well defined as the far side of L’Alpe d’Huez.

graphic courtesy of the CDC

With the current influenza epidemic nearly ended, the season’s numbers paint a decidedly benign picture. So far, 22 children have died from influenza; if that figure continues to grow as it has so far it will top out as the lowest since the CDC began collecting these data in 2004.

Other markers of how mild the 2011-2012 season has been include the number of U.S. patients hospitalized for influenza, which sits below past seasons, and the proportion of deaths attributable to pneumonia or influenza has hovered below the epidemic threshold for that measure all season.

During a winter and spring where the influenza world focused on mammalian-transmissible H5N1 flu, strains dubbed by some the “doomsday” virus, having such a mild seasonal flu season tossed at us can’t help but be seen as some ironic, natural-world prank. On a purely rationale basis, year-to-year variations in seasonal flu have nothing whatsoever to do with the looming danger from H5N1 flu, but with this infectious-disease juxtaposition I can’t help but imagine that somewhere, off in the distance, I hear a quiet, cosmic chortle.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Beauty Poisoning

Foreign-made skin-lightening creams, found to contain toxic levels of mercury, are poisoning users as well as the people they live with, according to a report from the Centers for Disease Control and Prevention.

The CDC identified a Mexican-made cream as the likely source of mercury exposure in 22 people in 5 households in California and Virginia. While previous cases have shows similar levels of mercury exposure from skin-lightening creams, this is the first instance where exposure has been measured in non-users, CDC said. The non-labeled creams contained  2%-5.7% mercury.

Skin lightening agents that are readily available for sale in Ghana/ ©2011 Elsevier Inc. All rights reserved.

Among the sample, 15 people ages 8 months to 67 years had elevated urinary mercury concentrations (9 users and 6 non-users). Non-users were exposed to the mercury through contact with cream users or with contaminated household items, the CDC said.  Younger children, compared to older children, had much higher concentrations.

While 15 people had elevated mercury levels, only 6 (all users) exhibited symptoms of mercury exposure. Users of the skin-lightening creams said they had used it as an acne treatment, for skin-lightening, and to fade freckles.

Although mercury-containing creams are banned by the Food and Drug Administration, high levels of mercury have been found in foreign-made skin-lightening creams across the country, including Chicago, New York, Minnesota, and Baltimore.

In 2010, an FDA spokesperson told the Chicago Tribune that with fewer than 500 inspectors dedicated to reviewing imports, banned items often get through anyway. The FDA could not comment before press time.

The CDC advises clinicians who recognize mercury toxicity to consider mercury-containing creams as a possible cause, even for children. Consult a medical toxicologist before beginning treatment, CDC advises.

—Frances Correa (@FMCReporting on Twitter)

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Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Smoking Scenes in Youth-Rated Movies Decline, But More Work Remains

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For the fifth year in a row, the number of smoking scenes in major youth-rated movies has declined, according to a report by the Centers for Disease Control and Prevention. In addition, the percentage of top-grossing movies with no tobacco incidents were the highest in 2010 compared with the last 20 years.

The report, Smoking in Top-Grossing Movies – United States 2010,  showed that the number of onscreen tobacco incidents in youth-rated movies (G, PG, or PG-13) dropped from 2,093 in 2005 to 595 in 2010. That’s almost a 72% decrease.

That’s the good news.

The bad news is that one in five high school students still smoke and “there’s still a substantial amount of smoking in youth-related films,” said Stanton A. Glantz, Ph.D., one of the study authors and director of Smoke Free Movies, in a news conference.

Several studies have indicated that smoking in movies increases the odds smoking initiation among youth.

Physicians ought to be educating parents that this is a real problem and that they should not let their youth watch movies that have smoking in them, said Dr. Glantz in a phone interview. His Web site lists the smoking status of top-grossing movies every week.

The report is also the first to look at the impact of policy. Three of the six major studios which have adopted a smoking-reduction policies between 2004 and 2007 had lowered their on-screen smoking incidents much more than those studios with no policy in place.

“The data find that three major movie studios (Comcast/Universal, Disney and Time Warner/Warner Bros.) have almost eliminated tobacco from their youth-rated movies, reducing the number of tobacco incidents per film (G/PG/PG13) by 96 percent.  In contrast, studios without policies as well as independent companies (News Corporation/Twentieth Century Fox, Sony/Columbia/Screen Gems and Viacom/Paramount) reduced tobacco depictions in youth-rated movies by an average of only 42 percent over the same period,” according to a news release by the Legacy for Longer Healthier Lives, which hosted a news conference following the report’s release.

The authors admit that implementation of policy won’t affect youths exposure to older movies and that youths do watch R-rated movies, but they recommend several solutions.

They suggest anti-tobacco ads before the movies that have smoking scenes. They also recommend expanding the R rating to include movies with smoking as one way to reduce adolescent exposure to on-screen smoking.

“And if you want to get politically involved,” said Dr. Glantz, “work with your state to stop subsidizing movies with smoking in them.” Almost all states offer movie producers subsidies in the form of tax credit or cash rebates to attract movie production to their states, according to the CDC report. “The 15 states subsidizing top-grossing movies with tobacco incidents spent more on these productions in 2010 ($288 million) than they budgeted for their state tobacco-control programs in 2011 ($280 million),” the authors write.

The authors used data from the Thumbs Up! Thumbs Down! project, which counts occurrences of tobacco incidents in U.S. top-grossing movies each year, to update their 2010 report.

By Naseem S. Miller (@ReportingBack)

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Fear Factor: Sending the Right Messages on Vaccine Safety

Parents don’t need another reason to worry about vaccinating their children. That was the general view during a discussion of febrile seizures at the June meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

 

ACIP’s general recommendations working group has a subgroup dedicated to febrile seizures. One job of this subgroup is to review data on what is known about the incidence of febrile seizures associated with various childhood vaccines alone or in combination. The bottom line: the working group decided to recommend that ACIP NOT make a recommendation about vaccination and febrile seizures.

courtesy of flickr user hartland martin (creative commons)

Several presentations included data showing that febrile seizures are neither unusual nor significantly associated with vaccinations. Dr. Andrew Kroger of the CDC acknowledged that data are limited, especially data on the risk/benefit ratios of simultaneous vaccinations and febrile seizures.

“How much risk of influenza and invasive pneumococcal disease are we willing to take with delayed vaccination, in order to prevent the occurrence of febrile seizures?” Dr. Kroger asked.

Ultimately, the working group decided that, for now at least, the issue was “best addressed through messaging,” rather than voting. A majority of the working group recommended that providers should simply inform parents of the increased risk of febrile seizures with concomitant vaccinations but not recommend any delay of vaccination because of it.

This option seemed to go over well during the discussion period.   

“The worst thing we could do is send a message that delaying vaccinations is preferable to preventing febrile seizures,” Dr. Michael Brady, representing the American Academy of Pediatrics, said during the discussion period. 

courtesy of flickr user Jimee, Jackie, Tom & Asha (creative commons)

Dr. Doug Campos-Outcalt, representing the American Academy of Family Physicians, agreed. “It’s important to consider febrile seizure numbers in the context of the disease,” he said.

ACIP member Dr. Janet Englund noted that “for ACIP to mandate discussion of febrile seizures during a visit would be harmful to the [vaccination] process.”

In fact, some data suggest that vaccination has a protective effect on febrile seizures, and such data could be useful when collected over the long term, said Dr. Jeff Duchin, chair of the general recommendations working group.

Hmm. Something else to encourage childhood vaccination. That sounds like a good message.

–Heidi Splete (on twitter @hsplete)

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The Value of Sleep

Sleep is big business. People need it. They want it. They’ll spend money to get it. And, according to the bulk of presentations at the 25th annual joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society in Minneapolis (SLEEP 2011) last week, the demand for it continues to far outpace the supply. Given these conditions, it’s not surprising that Americans spend nearly $24 billion on sleep-related goods and services annually, and the market for insomnia drugs is predicted to grow by nearly 80%, to approximately $3.9 billion, in 2012, according to market research conducted by Marketdata Enterprises.

Image via Flickr user deansouglass by Creative Commons License.

Evidence of the anything-but-restful sleep market was plentiful in the SLEEP 2011 exhibit hall, with booth after booth of vendors showcasing everything from pharmaceuticals and nutraceuticals to earplugs, continuous positive airway pressure devices, breathing masks, light therapy boxes, aromatherapy sprays, premium mattresses, and customized pillows. There was also row upon row of posters highlighting the latest research on the multiple and varied sleep-related problems that are keeping the vendors in business.

During a walk through the exhibit hall, however, it didn’t take long for the ironic reality of the sleep conundrum to set in. Americans are spending billions of dollars on sleep-related goods and services and researchers are spending billions of dollars seeking insight into the global sleep deficit that, according to the meeting’s scientific program presentations, is leaving children, adolescents, and adults overtired, anxious, depressed, and suboptimally functional and is putting them at risk for a range of adverse health outcomes, including cardiovascular disease, asthma, diabetes, stroke, and obesity. Yet we, as a society, don’t value sleep.

For example, in March of this year, the Centers for Disease Control and Prevention reported that nearly one third of the country’s adults get less than the minimum recommended 7 hours of sleep per night, and it’s not because they’re not tired: nearly 40% of the survey population reported unintentionally falling asleep during the day and nearly 5% reported nodding off while driving in the preceding 30 days.

Notwithstanding suboptimal sleep quality or quantity resulting from chronic sleep disorders, such as insomnia, obstructive sleep apnea, restless leg syndrome, bruxism, narcolepsy, and sleepwalking, the country’s pervasive sleepiness is often a symptom of what has become a “24-hour society,” in which there’s not enough time in a day to do everything we want to do, according to Dr. Michel Cramer Bornemann, co-director of the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center in Minneapolis. Not only have we become accustomed to trading sleep for work, he said in a session on sleep forensics, “we wear sleep deprivation as a badge of honor, as if lack of sleep is synonymous with hard work or achievement, when really it can impede both.”

Sleep is a biological imperative, Dr. Bornemann stressed. When it’s not valued as such,  “everybody pays.”

— Diana Mahoney (on Twitter @DMPM1)

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Stroke Hospitalizations Increase in Young Adults

I bet a lot of people jumped to conclusions when the U.S. Centers for Disease Control and Prevention (CDC) announced that hospitalizations of some young people for acute ischemic stroke increased by as much as 53% between 1994-1995 and 2006-2007. I know that the first thought crossing my mind was, “Blame the obesity epidemic.”

Photo courtesy flickr user wsilver.

But it’s not that simple, and the story illustrates the many nuances of interpreting medical and epidemiologic studies. For one thing, note that the CDC studied hospitalization rates, not stroke rates, so the study isn’t necessarily saying that young people are having more strokes. You can’t make that assumption. Other factors may have led to more hospitalizations.

Also, hospitalizations for stroke increased or decreased in different age groups, Dr. Mary G. George of the CDC and her associates reported at the International Stroke Conference. That led some physicians at the meeting to pat themselves on the back, believing that their efforts helped decrease stroke hospitalizations in adults aged 45-64 or 65 and older, while others scratched their heads over increased stroke hospitalizations in three younger age groups: 5-14 years; 15-34 years, and 35-44 years. The youngest age group diverged by sex, with a decrease in stroke hospitalizations in females and no significant change in males aged 0-4 years.

As alarming as it sounds to hear that more teenagers and young adults are being hospitalized for stroke, it’s important to keep in mind that these are still rare. For example, the biggest increase in stroke hospitalizations — a 53% jump — was seen in young men aged 15-34 years. But in absolute terms, only 15 of every 10,000 men in that age group who were hospitalized in 2006-2007 had acute ischemic strokes.

I certainly don’t mean to dismiss concerns about the obesity epidemic and other risk factors for stroke such as hypertension and diabetes, or about increased stroke hospitalizations in some age groups. But Dr. Lee H. Schwamm, director of telestroke and acute stroke services at Massachusetts General Hospital, Boston, explained how these are unlikely to be the cause of increased stroke hospitalizations in young people. Listen to this podcast with Dr. Schwamm, created from interviews released by the American Heart Association and American Stroke, which sponsored the meeting.

Whatever factors may be responsible for increased stroke hospitalizations in young people, we’ve still got to decrease the traditional risk factors for stroke (obesity, hypertension, diabetes), he emphasized, “otherwise we will have a wave of cardiovascular disease and stroke in the next 20-30 years.”

— Sherry Boschert (@sherryboschert)

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Oh Boy, Another Vaccine Conundrum

Should the human papillomavirus (HPV) vaccine Gardasil be recommended for routine use in boys aged 11-12 years, as it is now for girls? Or should the vaccine’s use in boys remain an option but not a routine recommendation? Alternatively, should it be routinely recommended for males who have sex with other males, a group that is at increased risk for anal infection and cancer due to HPV?

Policy decisions regarding vaccine use are often complex and nuanced, even for vaccines that aren’t already as controversial as Gardasil. The issue of vaccinating males is causing headaches for the panel tasked with making the decision, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Pat Ramsey photo via Flickr Creative Commons

Of the two HPV vaccines on the U.S. market, only Gardasil is licensed for use in males. It contains four strains of HPV, two (16 and 18) that are associated with cervical and other types of anogenital and oral cancers, and two (6 and 11) that are associated with genital warts. In December 2010, the Food and Drug Administration added the indication of prevention of anal cancer due to HPV vaccine strains in both males and females.

In 2009, ACIP said that Gardasil could be given to males aged 9 through 26 years, but didn’t make a routine recommendation. Some are now in favor of doing so, arguing that the vaccine protects males against both genital warts and anal cancer, it reduces HPV transmission to females by preventing infection in their male sex partners, and it’s simply more equitable and convenient for physicians to offer the vaccine to both male and female patients.

The main argument against the move is the vaccine’s cost, approximately $360 for the full three-dose series. A CDC-commissioned cost-effectiveness analysis posed a conundrum: Use of Gardasil in males is more cost-effective the less it is used in females, and vice versa. At current female coverage levels – just 27% for all three doses among 13- to 17-year-olds in 2009 ¬ use of the vaccine in males makes the cost-effectiveness cut-off in some models, depending on assumptions. But of course, public health officials are hoping that coverage among females will increase.

Restricting Gardasil’s use to males who have sex with males would dramatically increase the vaccine’s cost-effectiveness, as anal cancer in that group is actually more common than is cervical cancer among all women. While the vaccine’s use could certainly be promoted among older male teens and young adults who are already “out,” screening for sexual orientation among 11- to 12-year-old boys is unlikely to be a viable option.

A vote on this is likely to come later this year, but it won’t be an easy one, ACIP working group chair Dr. Janet A. Englund told me at the panel’s meeting last week in Atlanta. “The concern about cost and cost-effectiveness is a very important consideration for the committee.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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